What type of study is this?

This is a Systematic Review study.

December 5, 2025Open Access

Clinical Efficacy and Safety of Topical Roflumilast in Psoriasis: An Updated Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Key Points

Topical roflumilast significantly improved efficacy outcomes for plaque psoriasis, demonstrating therapeutic promise.
Efficacy metrics included notable improvements in Investigator's Global Assessment and PASI scores at 8 weeks.
The systematic review analyzed data from five randomized controlled trials with 1835 total patients.
Increased adverse events were noted, requiring consideration in clinical practice for patient management.

Abstract

ABSTRACT Background Traditional first‐line topical treatments for plaque psoriasis, particularly corticosteroids and vitamin D analogs, frequently have only limited efficacy for long‐term use, and present difficulties with safety and adherence. Objectives In this systematic review and meta‐analysis of randomized controlled trials (RCTs), we assessed the efficacy and safety of topical roflumilast 0.3% in patients with plaque psoriasis. Methods We searched the Cochrane CENTRAL, Embase, ClinicalTrials.gov, and PubMed databases from inception to May 2025 to identify relevant randomized clinical trials. Examined outcomes included Investigator's Global Assessment (IGA) or body‐IGA success (defined as clear or almost clear skin with at least a two‐grade improvement from baseline), scalp‐IGA (S‐IGA), intertriginous‐IGA (clear or almost clear status on the intertriginous‐IGA plus an at least 2‐grade improvement from baseline), Psoriasis Area and Severity Index (PASI)‐50, PASI‐75, PASI‐90, and PSSI‐75 (Psoriasis Scalp Severity Index 75%). Worst Itch‐Numeric Rating Scale (WI‐NRS) success, Psoriasis Symptoms Diary (PSD) score at 8 weeks, and adverse events (AEs) were also assessed. Statistical analysis was performed using Review Manager, while heterogeneity was quantified using the Higgins I² index. Results Analysis of five RCTs (1835 patients) showed topical roflumilast 0.3% improved IGA/body‐IGA (RR: 4.19; 95% CI: 2.49–7.04; p < 0.00001), S‐IGA (RR: 3.37; 95% CI: 1.57–7.25; p = 0.002), and I‐IGA (RR: 3.32; 95% CI: 2.11–5.22; p < 0.00001) at 8 weeks. It also increased PASI‐50, PASI‐75, PASI‐90, and PSSI‐75 success (RRs: 2.55–4.32; p < 0.00001). WI‐NRS success (RR: 2.12; 95% CI: 1.74–2.60) and PSD (MD: –25.34; 95% CI: –31.77 to –18.92) improved significantly. Adverse events were more frequent in the intervention group (RR: 1.29; 95% CI: 1.08–1.54; p = 0.004). Conclusions These findings demonstrate that topical roflumilast 0.3% outperformed vehicle in efficacy and safety profile, underscoring its therapeutic potential in plaque psoriasis management.

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